Planned Construction And Use Of The International Histio Net Data Base

All project partners – including Europe’s most important actors in collecting data about histiocytosis patients – were asked to provide information about their existing data bases and to send a list of their catalogue of data. Based on the returned information, a catalogue of all data collected was compiled and a set of mandatory data was commonly decided. The future database will support all data currently collected by interested contributors. This implicates the need of a very comprehensive data collection (catalogue of data), but will assure the support of the most experienced national networks in Europe. The definition of a small set of mandatory data will enable less experienced contributors to build up patient registries for their countries and to extend their data collections continuously upon their needs. An extension of the complete catalogue will be possible on the basis of a scientific concept.

In order not to scare the users of the data base off, only a few fields will be visible at the beginning of data entry. Once special fields are chosen based on the patient’s special clinical circumstances, additional lists will open up to specify the conditions. The planned construction of the data base is well adapted to the very special conditions of a single patient: For many children for example, no lung involvement is seen and no fields must be completed. In contrast, lung involvement is seen in many adult patients as exclusive presentation of the disease which needs a careful investigation in order to answer questions which will be needed for the development of guidelines for adult patients.

The users of the data base will not be obliged to supply the whole catalogue of data but will have to complete the mandatory patient registry. The database will guarantee to them full responsibility for the use of their data. Use of the data base will require informed patient consent for all types of data storage and oversight by an ethics review committee will be required in case that data is collected for research use, so to assess and ensure that the benefits of the research outweigh the risks of the patients’ participation. Each data controller will have to confirm that the informed patient consent was obtained in writing and that it complies with GCP and all applicable legal regulations. Euro-Histio-Net will recommend to all users of the data base to ask their patients to consent for a broad use, because it is difficult to foresee all the potential research applications that a data collection may be used for.